tag:blogger.com,1999:blog-9076190155284676524.post2683246561570607125..comments2024-03-18T17:54:37.827-04:00Comments on Your Diabetes May Vary: Should Diabetes be on the Agenda of Upcoming FDA Public Meetings? Unknownnoreply@blogger.comBlogger3125tag:blogger.com,1999:blog-9076190155284676524.post-44559658031804398972012-10-02T17:29:21.703-04:002012-10-02T17:29:21.703-04:00Comment Tracker 1jw-816l-dnlh.
Thanks Bennet!Comment Tracker 1jw-816l-dnlh.<br /><br />Thanks Bennet!Scott K. Johnsonhttps://www.blogger.com/profile/17881833642347872927noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-13796850924948712112012-09-27T07:58:15.072-04:002012-09-27T07:58:15.072-04:00My Comment Tracking Number: 8112a57cMy Comment Tracking Number: 8112a57cBennethttps://www.blogger.com/profile/17411395744352827620noreply@blogger.comtag:blogger.com,1999:blog-9076190155284676524.post-35367301399038133572012-09-26T12:30:21.169-04:002012-09-26T12:30:21.169-04:00Note that the announcement claims "FDA will c...Note that the announcement claims "FDA will conduct public meetings for 20 different disease areas. The meetings will focus on the patient perspective regarding two key considerations in FDA’s regulatory decision-making: the severity of the disease and the currently available treatment options." The FDA perception is undoubtedly that a) the "severity" of diabetes is relatively low given that there ARE effective treatments for all types of diabetes. Again, the idea that patients' failure to meet treatment goals is not indicative of an ineffective treatment, rather they point to issues such as noncompliance, lack of patient education, etc. but the treatments themselves are not questioned. Again, I believe that the focus on diabetes-related complications, rather than the disease itself, is a mistake on the part of the FDA in this case. Most (but not all) diabetes complications can be avoided with proper management, but the FDA is considering patient input on treatments for complications, but not for treatments (insulin, biotech drugs, medical devices) for diabetes itself.<br /><br />I'd like to see just how the FDA responds to the question about the selection of disease states they are focusing on. Perhaps a call to the Office of Special Health Issues is in order here?Scott Shttps://www.blogger.com/profile/03286529314567223617noreply@blogger.com